GS Medical AnyPlus PEEK Cage System

K200592 · GS Medical Co., Ltd. · ODP · Aug 10, 2020 · Orthopedic

Device Facts

• Record ID: K200592
• Device Name: GS Medical AnyPlus PEEK Cage System
• Applicant: GS Medical Co., Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Aug 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GS Medical AnyPlus® PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical The GS Medical AnyPlus® PEEK Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical The GS Medical AnyPlus® PEEK Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non- operative treatment prior to treatment with an intervertebral cage.

Device Story

Intervertebral body fusion device; restores intervertebral space height after disc resection; facilitates fusion in cervical spine (C3-C7). Implant features open architecture for autograft bone packing; available in various heights and lordotic configurations. Used by surgeons in clinical settings; requires supplemental fixation. Radiolucent PEEK body with radio-opaque Tantalum markers allows X-ray visualization for placement verification. Single-use device.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: PEEK (ASTM F2026:17), Unalloyed Tantalum (ASTM F560-17), Wrought Stainless Steel (ASTM F899-19). Design: Open architecture cage for bone graft. Testing: ASTM F2077-11 (static/dynamic axial compression, compression-shear, torsion, expulsion) and ASTM F2267-04 (subsidence). Sterile and non-sterile options.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one level (C3-C7) with radicular symptoms. DDD defined as discogenic pain confirmed by history/radiography. Requires autograft bone and supplemental fixation. Patients must have failed at least 6 weeks of non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• GS Medical AnyPlus® Cervical PEEK Cage (K153517)

Submission Summary (Full Text)

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August 10, 2020

GS Medical Co., Ltd. % Mr. Barry Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K200592

Trade/Device Name: The GS Medical AnyPlus® PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 10, 2020 Received: July 15, 2020

Dear Mr. Sands:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

### K200592

Device Name GS Medical AnyPlus® PEEK Cage System

### Indications for Use (Describe)

The GS Medical AnyPlus® PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical AnyPlus® PEEK Cage System are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical AnyPlus® PEEK Cage System are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY

## GS Medical Co., Ltd.

# AnyPlus® PEEK Cage System

| Manufacturer: | GS Medical Co.,Ltd.<br>90, Osongsaengmyeong 4-ro<br>Osong-eup<br>Cheongwon-gun<br>Chungcheongbuk-do<br>363-951 Korea | |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Date: | March 2, 2020 | |
| Submitted by: | GS Medical Co.,Ltd | |
| Company Contact | Andrea Watt<br>[phone]<br>[e-mail] | |
| US Agent Information<br>Official Correspondent | RQMIS Inc.<br>Mr. Barry E. Sands<br>110 Haverhill Rd, Suite 526<br>Amesbury, MA 01913<br>Ph: 978-358-7307<br>[e-mail] | |
| Proprietary Name: | The GS Medical AnyPlus® PEEK Cage System | |
| Performance standards: | The GS Medical AnyPlus® PEEK Cage System was non-<br>clinically tested according to the ASTM 2077-11 and ASTM<br>F2267-04 performance standards. | |
| Regulation:<br>Common/Usual Name:<br>Classification name:<br>Review Panel:<br>Product Code:<br>Device Class: | 21 CFR 888.3080<br>Cervical Spinal Fusion Device, IBF Device<br>Intervertebral body fusion device - Cervical<br>Orthopedic<br>ODP<br>Class II | |
| Substantial Equivalence: | Substantial equivalence for the GS Medical AnyPlus® PEEK<br>Cage System is based on its similarities in indications for use,<br>design features, operational principles and material<br>composition when compared to the predicate devices. | |
| Primary Predicate Device: | K153517 GS Medical AnyPlus® Cervical PEEK Cage<br>The subject device is substantially equivalent to similar previously cleared devices. | |
| Device Description: | The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether- ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine. | |
| Intended Use: | The GS Medical AnyPlus® PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical The GS Medical AnyPlus® PEEK Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical The GS Medical AnyPlus® PEEK Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non- operative treatment prior to treatment with an intervertebral cage. | |
| Summary of Technological<br>Characteristics | The GS Medical AnyPlus® PEEK Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The GS Medical AnyPlus® PEEK Cage System device consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether- ketone (PEEK) body with the x-ray markers made of Tantalum. The intended use, technological characteristics, mode of action and materials of construction are the same as those of the referenced predicate devices. | |
| Device Materials | Material | Standard |
| | Polyether-ether-ketone (PEEK) | ASTM F2026:17 |
| | Unalloyed Tantalum | ASTM F560-17 |
| | Wrought Stainless Steel | ASTM F899-19 |
| Non-Clinical Testing | The GS Medical AnyPlus® PEEK Cage System devices were<br>tested according to the ASTM 2077, specifically, Static and<br>Dynamic Axial Compression, Static and Dynamic Compression-<br>Shear Testing, Static and Dynamic Torsion Testing Expulsion<br>Testing and Static Subsidence testing under Axial<br>Compression, per ASTM 2267. All performance test results<br>were equivalent to or higher than a legally marketed predicate<br>device. Pyrogen limit specifications were tested and met on<br>"worst-case" model, complying with FDA guidance an<br>specifications. | |
| Clinical Testing | No clinical testing was performed. | |
| Conclusion | The GS Medical AnyPlus® PEEK Cage System has the same<br>intended use and similar indications, principles of operation,<br>and technological characteristics as the predicate device. The<br>minor differences in the designs do not raise any new<br>questions of safety or effectiveness. Performance data<br>demonstrates that the AnyPlus® Cervical PEEK Cage System<br>are as safe and effective as the predicate device. Thus, the<br>AnyPlus® Cervical PEEK Cage System is substantially<br>equivalent to the predicate device. | |

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